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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Multiple approaches for subject recruitment were implemented.The Center for Innovation in Restorative (CIRM) hired a marketing specialist who investigated the use of non-traditional mechanisms within and outside the existing infrastructure including but not limited to social media outlet,use of internal/external physician networks,TV advertising

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

All of the subjects who were enrolled (signed consent) were randomized to 1 of 4 cohorts.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

No Injection

Empty safety control, no injection

Vehicle Only

Vehicle only (0.5 ml of HypoThermosol solution)

Single Admin Day 0

5 million cells / cm² , single administration at Day 0

Single Admin Day 28

5 million cells/ cm² , single administration at day 28

Admin Day 0 and 28

5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28